Pilot Human Laboratory Study of Alcohol Approach Bias Modification (AABM) for Alcohol Use Disorder (AUD)

NCT03898323 | Completed Results FDA Device

• 1 other identifier: UCSF REAC RAP
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of the proposed project is to improve the treatment of individuals with Alcohol Use Disorder (AUD). We will conduct a pilot feasibility trial of Approach Bias Modification (AABM) training of heavy-drinking non-treatment seeking individuals with AUD. We will measure feasibility with respect to recruitment, retention and tolerability of AABM training and the Alcohol Drinking Paradigm (ADP). We will also assess changes in alcohol craving and alcohol consumption during ADP sessions conducted before and after 2 weeks of AABM training.

Conditions

Alcohol Use Disorder

Keywords

human laboratory; alcohol approach bias modification; alcohol use disorder; non-treatment seeking

Outcome Measures

Primary Outcomes (3)

• Recruitment Feasibility

  The number of participants who enrolled and actually started study treatment over the 12-month recruitment period.

  12 months

• Retention Feasibility

  Retention feasibility as measured by the percentage of participants completing Alcohol Drinking Paradigm (ADP) sessions 1 and 2 and completing the 2-week course of 6 AABM training sessions.

  6 weeks

• Tolerability Feasibility

  Tolerability feasibility is measured by the number and percent of participants experiencing each adverse event.

  6 weeks

Secondary Outcomes (2)

• Alcohol Craving

  6 weeks

• Alcohol Consumption (Number of Standard Drinks Consumed)

  2 days (1 day each for ADP session 1 and 2)

Study Arms (1)

AABM Training

EXPERIMENTAL

Alcohol Approach Bias Modification (AABM) training is a computer training program that participants interact with by pushing and pulling a joystick. Participants are asked to respond to the format of a presented picture, irrespective of the pictures' content. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. AABM training consists of 3 sessions per week over 2 weeks, for a total of 6 sessions.

Device: Alcohol Approach Bias Modification

Interventions

Alcohol Approach Bias Modification DEVICE

Computerized training

AABM Training

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men, ages 21-50;
• Able to read English and to complete study evaluations;
• Risky (also known as high-risk, or hazardous, or heavy) alcohol use, defined as 25-70 standard drinks per week on average over the past 30 days; Heavy (also known as risky, high-risk, or hazardous) alcohol use, defined as 15-70 standard drinks per week on average over the past 30 days.
• No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions.
• At least 1 heavy drinking day (\> 5 drinks/day) per week on average during the 30 days prior to screening.

You may not qualify if:

• Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
• Current DSM-V non-alcohol use disorder other than tobacco and marijuana;
• Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines, or barbiturates;
• Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation;
• Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
• Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol or would make study participation hazardous;
• History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score \> 8;
• Participants who report disliking beer will be excluded because beer will be provided during the alcohol self-administration periods;
• Participants who have taken any investigational drug within 4 weeks preceding study entry.

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco VA Health Care System: collaborator

Study Sites (1)

San Francisco VA Health Care System

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Of the 3 participants who were assigned to study treatment and who actually started study treatment, 1 participant was withdrawn from the study after ADP session 1. The reason for the study withdrawal was because of study physician decision, based on laboratory test evidence of substance use, making the participant ineligible for study continuation.

Results Point of Contact

• Title: Steven L. Batki, MD
• Organization: University of California, San Francisco/San Francisco VA Health Care System

steven.batki@ucsf.edu

415-221-4810

Study Officials

• Steven L. Batki, MD

  University of California, San Francisco/San Francisco VA Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: April 1, 2019
• Study Start: February 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)